NCT07262281

Evaluation of the Safety, Tolerability and Pharmacokinetics of HY6725 in Healthy Adult Participants

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HY6725 Following Single and Multiple Subcutaneous Doses in Healthy Participants

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Newsoara Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to learn the safety, tolerability and pharmacokinetics of single and multiple doses of HY6725 in healthy adult participants. The main questions it aims to answer are: * How is the safety and tolerability following administration of single and multiple doses of HY6725 in healthy adult participants? * What is the PK character of HY6725 following administration of single and multiple doses of HY6725 in healthy adult participants? Researchers will compare HY6725 to a placebo (a look-alike substance that contains no drug) to see if HY6725 is safe and well tolerated. Participants will take HY6725 or a placebo once or twice in single dose group or multiple dose group. And will be follow-up until Day 150.

Detailed description

The rationale of the study is HY6725 is a novel, fully human monoclonal antibody engineered to simultaneously neutralize human TSLP and IL-33. Given the overlapping, synergistic, and compensatory roles of TSLP and IL-33 in the pathogenesis of asthma and COPD-as well as in other chronic type 2 inflammatory diseases-simultaneous inhibition offers a promising therapeutic strategy.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	HY6725	HY6725 is an injection solution with 120mg/ml per vial. SAD part for subcutaneous dosing in 7 cohorts, including 3mg, 10mg, 30mg, 90mg, 150mg, 300mg and 450mg with only one administration on Day 1 of each cohort. MAD part for subcutaneous dosing in 3 cohorts, including 150mg, 300mg and 450mg with two administrations on Day 1 and Day 30 of each cohort.
OTHER	Placebo Control	A vial with 1ml injection solution contain same ingredient except HY6725 compared with HY6725 solution.

Timeline

• Start date: 2026-02-06
• Primary completion: 2027-03-01
• Completion: 2027-04-01
• First posted: 2025-12-03
• Last updated: 2026-03-11

Locations

1 site across 1 country: Australia